Motor Evoked Potential MonitoringNCT01690364
Comparison of the Effects of Vecuronium and Cisatracurium on Electrophysiologic Monitoring During Neurosurgery
A study testing MEP monitoring with continuous infusion of vecuronium during general anesthesia and MEP monitoring with continuous infusion of cisatracurium during general anesthesia in people with Motor Evoked Potential Monitoring and General Anesthesia, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
Recently intraoperative motor evoked potential monitoring (MEP) is widely used to reduce neural damage during neurosurgery. As neuromuscular blockade(NMB) during MEP monitoring decreases the amplitude of MEP, partial NMB is usually maintained during general anesthesia. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Motor Evoked Potential Monitoring, General Anesthesia, Neurosurgery
- What is being tested?
- MEP monitoring with continuous infusion of vecuronium during general anesthesia and MEP monitoring with continuous infusion of cisatracurium during general anesthesia
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jul 2012to Mar 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients undergoing neurosurgery with intraoperative motor evoked potential monitoring
Who cannot join
- Patients who can not undergo motor evoked potential monitoring due to central or peripheral neuromuscular disease (e.g. Cerebral palsy, Myasthenia gravis, Acute spinal injury, neurologic shock)
- Patients with hepatic or renal disease with altered metabolism of vecuronium
- Patients with medication which influence the metabolism of vecuronium (e.g. calcium channel blocker, aminoglycoside antibiotics, Lithium, MgSO4)
Trial locations and contacts
1 site in 1 country.
About this study
Recently intraoperative motor evoked potential monitoring (MEP) is widely used to reduce neural damage during neurosurgery.
As neuromuscular blockade(NMB) during MEP monitoring decreases the amplitude of MEP, partial NMB is usually maintained during general anesthesia. Continuous infusion of NMB agent is preferred than bolus infusion during MEP monitoring. There are a lot of NMB agents in clinical use. But there have been no reports about the effect of changing NMB agent on efficacy of MEP monitoring.
Therefore, the investigators performed a randomized controlled trial to evaluate the effect of changing NMB agent on the variability of MEP amplitude during neurosurgery.
Read the detailed description
Recently intraoperative motor evoked potential monitoring (MEP) is widely used to reduce neural damage during neurosurgery.
As neuromuscular blockade(NMB) during MEP monitoring decreases the amplitude of MEP, partial NMB is usually maintained during general anesthesia. Continuous infusion of NMB agent is preferred than bolus infusion during MEP monitoring. There are a lot of NMB agents in clinical use. But there have been no reports about the effect of changing NMB agent on efficacy of MEP monitoring.
Therefore, the investigators performed a randomized controlled trial to evaluate the effect of changing NMB agent on the variability of MEP amplitude during neurosurgery.
- Conditions
- Motor Evoked Potential Monitoring, General Anesthesia, Neurosurgery, Brain Tumor, Spine Tumor, Cerebral Aneurysm
- Being tested
- MEP monitoring with continuous infusion of vecuronium during general anesthesia, MEP monitoring with continuous infusion of cisatracurium during general anesthesia
- Keywords
- Motor evoked potential monitoring, General Anesthesia, Neurosurgery, Cisatracurium, Vecuronium
- Medical subject headings
- Brain Neoplasms, Intracranial Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MEP monitoring with continuous infusion of vecuronium during general anesthesiaOther
MEP monitoring with continuous infusion of vecuronium during general anesthesia
MEP monitoring with continuous infusion of cisatracurium during general anesthesiaOther
MEP monitoring with continuous infusion of cisatracurium during general anesthesia
| Study group | Role | What they receive |
|---|---|---|
| Cisatracurium Group | Experimental | MEP monitoring with continuous infusion of cisatracurium during general anesthesia Receives: Other: MEP monitoring with continuous infusion of cisatracurium during general anesthesia |
| Vecuronium Group | Active comparator | MEP monitoring with continuous infusion of vecuronium during general anesthesia Receives: Other: MEP monitoring with continuous infusion of vecuronium during general anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
MEP amplitude
intraoperative motor evoked potential monitoring amplitude
Measured: 15 min after anesthetic induction
MEP amplitude
intraoperative motor evoked potential monitoring amplitude
Measured: 30 min after anesthetic induction
MEP amplitude
intraoperative motor evoked potential monitoring amplitude
Measured: 45 min after anesthetic induction
MEP amplitude
intraoperative motor evoked potential monitoring amplitude
Measured: 60 min after anesthetic induction
MEP amplitude
intraoperative motor evoked potential monitoring amplitude
Measured: 75 min after anesthetic induction
MEP amplitude
intraoperative motor evoked potential monitoring amplitude
Measured: 90 min after anesthetic induction
MEP amplitude
intraoperative motor evoked potential monitoring amplitude
Measured: 105 min after anesthetic induction
MEP amplitude
intraoperative motor evoked potential monitoring amplitude
Measured: 120 min after anesthetic induction
MEP amplitude
intraoperative motor evoked potential monitoring amplitude
Measured: 135 min after anesthetic induction
MEP amplitude
intraoperative motor evoked potential monitoring amplitude
Measured: 150 min after anesthetic induction
MEP amplitude
intraoperative motor evoked potential monitoring amplitude
Measured: 165 min after anesthetic induction
MEP amplitude
intraoperative motor evoked potential monitoring amplitude
Measured: 180 min after anesthetic induction
MEP amplitude
intraoperative motor evoked potential monitoring amplitude
Measured: 195 min after anesthetic induction
MEP amplitude
intraoperative motor evoked potential monitoring amplitude
Measured: 210 min after anesthetic induction
MEP amplitude
intraoperative motor evoked potential monitoring amplitude
Measured: 225 min after anesthetic induction
MEP amplitude
intraoperative motor evoked potential monitoring amplitude
Measured: 240 min after anesthetic induction
MEP amplitude
intraoperative motor evoked potential monitoring amplitude
Measured: 255 min after anesthetic induction
MEP amplitude
intraoperative motor evoked potential monitoring amplitude
Measured: 270 min after anesthetic induction
MEP amplitude
intraoperative motor evoked potential monitoring amplitude
Measured: 285 min after anesthetic induction
MEP amplitude
intraoperative motor evoked potential monitoring amplitude
Measured: 300 min after anesthetic induction
Secondary outcomes (4)
Coefficient of variation (CV) of MEP amplitude
Coefficient of variation (CV) of intraoperative motor evoked potential monitoring amplitude
Measured: at the end of the surgery (5H after the start of surgery)
Average of MEP amplitudes
Average of all measured MEP amplitudes in a subject
Measured: at the end of the surgery (5H after the start of surgery)
The frequency of adjusting the infusion dose of muscle relaxant
The frequency of adjusting the infusion dose of muscle relaxant
Measured: at the end of the surgery (5H after the start of surgery)
Average of Latency of MEP amplitude
Average of Latency of MEP amplitude
Measured: at the end of the surgery (5H after the start of surgery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2012 (estimated)
- Study startJul 2012
- Primary completionMar 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Motor Evoked Potential MonitoringStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeong Jin Lee, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01690364
- Sponsor's protocol ID
- 2012-05-090-001
- Status last verified
- Dec 2013
- First submitted
- 10 Sep 2012
- Last updated
- 25 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effects of Vecuronium and Cisatracurium on Electrophysiologic Monitoring During Neurosurgery
- ClinicalTrials.gov ID
- NCT01690364
- Acronym / sponsor ID
- 2012-05-090-001
- Conditions
- Motor Evoked Potential Monitoring, General Anesthesia, Neurosurgery, Brain Tumor, Spine Tumor, Cerebral Aneurysm
- Keywords
- Motor evoked potential monitoring, General Anesthesia, Neurosurgery, Cisatracurium, Vecuronium
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 21 Sep 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Recently intraoperative motor evoked potential monitoring (MEP) is widely used to reduce neural damage during neurosurgery.
As neuromuscular blockade(NMB) during MEP monitoring decreases the amplitude of MEP, partial NMB is usually maintained during general anesthesia. Continuous infusion of NMB agent is preferred than bolus infusion during MEP monitoring. There are a lot of NMB agents in clinical use. But there have been no reports about the effect of changing NMB agent on efficacy of MEP monitoring.
Therefore, the investigators performed a randomized controlled trial to evaluate the effect of changing NMB agent on the variability of MEP amplitude during neurosurgery.
Detailed description
Recently intraoperative motor evoked potential monitoring (MEP) is widely used to reduce neural damage during neurosurgery.
As neuromuscular blockade(NMB) during MEP monitoring decreases the amplitude of MEP, partial NMB is usually maintained during general anesthesia. Continuous infusion of NMB agent is preferred than bolus infusion during MEP monitoring. There are a lot of NMB agents in clinical use. But there have been no reports about the effect of changing NMB agent on efficacy of MEP monitoring.
Therefore, the investigators performed a randomized controlled trial to evaluate the effect of changing NMB agent on the variability of MEP amplitude during neurosurgery.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cisatracurium Group | Experimental | Other: MEP monitoring with continuous infusion of cisatracurium during general anesthesiaMEP monitoring with continuous infusion of cisatracurium during general anesthesia |
| Vecuronium Group | Active comparator | Other: MEP monitoring with continuous infusion of vecuronium during general anesthesiaMEP monitoring with continuous infusion of vecuronium during general anesthesia |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients undergoing neurosurgery with intraoperative motor evoked potential monitoring
Key exclusion criteria (3 listed)
- Patients who can not undergo motor evoked potential monitoring due to central or peripheral neuromuscular disease (e.g. Cerebral palsy, Myasthenia gravis, Acute spinal injury, neurologic shock)
- Patients with hepatic or renal disease with altered metabolism of vecuronium
- Patients with medication which influence the metabolism of vecuronium (e.g. calcium channel blocker, aminoglycoside antibiotics, Lithium, MgSO4)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MEP monitoring with continuous infusion of vecuronium during general anesthesiaMEP monitoring with continuous infusion of vecuronium during general anesthesia | Other | Vecuronium Group |
| MEP monitoring with continuous infusion of cisatracurium during general anesthesiaMEP monitoring with continuous infusion of cisatracurium during general anesthesia | Other | Cisatracurium Group |
Primary outcome
MEP amplitude
Time frame: 15 min after anesthetic induction
intraoperative motor evoked potential monitoring amplitude
MEP amplitude
Time frame: 30 min after anesthetic induction
intraoperative motor evoked potential monitoring amplitude
MEP amplitude
Time frame: 45 min after anesthetic induction
intraoperative motor evoked potential monitoring amplitude
MEP amplitude
Time frame: 60 min after anesthetic induction
intraoperative motor evoked potential monitoring amplitude
MEP amplitude
Time frame: 75 min after anesthetic induction
intraoperative motor evoked potential monitoring amplitude
MEP amplitude
Time frame: 90 min after anesthetic induction
intraoperative motor evoked potential monitoring amplitude
MEP amplitude
Time frame: 105 min after anesthetic induction
intraoperative motor evoked potential monitoring amplitude
MEP amplitude
Time frame: 120 min after anesthetic induction
intraoperative motor evoked potential monitoring amplitude
MEP amplitude
Time frame: 135 min after anesthetic induction
intraoperative motor evoked potential monitoring amplitude
MEP amplitude
Time frame: 150 min after anesthetic induction
intraoperative motor evoked potential monitoring amplitude
MEP amplitude
Time frame: 165 min after anesthetic induction
intraoperative motor evoked potential monitoring amplitude
MEP amplitude
Time frame: 180 min after anesthetic induction
intraoperative motor evoked potential monitoring amplitude
MEP amplitude
Time frame: 195 min after anesthetic induction
intraoperative motor evoked potential monitoring amplitude
MEP amplitude
Time frame: 210 min after anesthetic induction
intraoperative motor evoked potential monitoring amplitude
MEP amplitude
Time frame: 225 min after anesthetic induction
intraoperative motor evoked potential monitoring amplitude
MEP amplitude
Time frame: 240 min after anesthetic induction
intraoperative motor evoked potential monitoring amplitude
MEP amplitude
Time frame: 255 min after anesthetic induction
intraoperative motor evoked potential monitoring amplitude
MEP amplitude
Time frame: 270 min after anesthetic induction
intraoperative motor evoked potential monitoring amplitude
MEP amplitude
Time frame: 285 min after anesthetic induction
intraoperative motor evoked potential monitoring amplitude
MEP amplitude
Time frame: 300 min after anesthetic induction
intraoperative motor evoked potential monitoring amplitude
4 secondary outcomes
Coefficient of variation (CV) of MEP amplitude
Time frame: at the end of the surgery (5H after the start of surgery)
Average of MEP amplitudes
Time frame: at the end of the surgery (5H after the start of surgery)
The frequency of adjusting the infusion dose of muscle relaxant
Time frame: at the end of the surgery (5H after the start of surgery)
Average of Latency of MEP amplitude
Time frame: at the end of the surgery (5H after the start of surgery)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Dec 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MEP monitoring with continuous infusion of vecuronium during general anesthesia and MEP monitoring with continuous infusion of cisatracurium during general anesthesia in people with Motor Evoked Potential Monitoring and General Anesthesia, run by Samsung Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MEP amplitude (time frame: 15 min after anesthetic induction). The study lists 20 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Dec 2013.